Oncostellae is a Santiago-based biopharmaceutical company focused on the discovery and development of proprietary drug candidates based on strong intellectual property and worldwide rights for immunological and oncological indications. The company was founded in 2013 by a group of medicinal chemists and pharmacologists led by Dr. Julio Castro and Professor Mabel Loza. "Our mission is to bring novel therapeutic solutions to patients suffering from diseases with a high unmet medical need. To achieve this mission, we have created a team of experienced and dedicated scientists with expertise in different disciplines and extensive experience in drug discovery and development," explains Guido Kurz, CEO of Oncostellae.

Its business model involves developing novel compounds from conception, through optimization in the laboratory and in animal models, to clinical proof-of-concept and then signing a licensing or co-development agreement with a pharmaceutical company that continues clinical development, registration and commercialization of the product. "In return, Oncostellae receives upfront and milestone payments, as well as royalties on sales when the product reaches the market," explains Kurz.

Main lines of research

Oncostellae is currently developing a drug to treat ulcerative colitis and another for colorectal cancer.

"With our lead asset, OST-122, we envision offering patients suffering from inflammatory bowel disease an effective and safe therapeutic solution that significantly improves their quality of life," explains Guido Kurz. OST-122 is a Jak kinase inhibitor restricted to the gastrointestinal tract for safer treatment of inflammatory bowel disease without inducing systemic toxicity, unlike other currently available Jak inhibitors. "It has recently completed a Phase 2 clinical study in patients with ulcerative colitis showing excellent safety and preliminary efficacy data," he advances.

The second drug candidate, OST-499, is intended for the treatment of colorectal cancer and other solid tumors. "It is a glucocorticoid receptor antagonist that has just completed a first-in-human Phase 1 trial and has demonstrated excellent safety at three ascending doses."

Oncostellae has recently received the Startup Award in the framework of the Conference "Investing in science is profitable. II Encuentro del Ecosistema de inversión en Ciencia y Tecnología Deep Tech", a recognition of its solid track record and impact, in which there has been no shortage of challenges to overcome. "The start-up of companies like Oncostellae, dedicated to a sector as risky but at the same time as necessary as drug discovery, is very long and very costly. Perhaps this second aspect, that of financing, has been the main challenge to overcome. The developments undertaken by the company, especially in the regulatory phases, both preclinical and clinical, require large financial outlays. In order to be able to carry them out, we have had to make major efforts to raise financing," he explains. 

Another important challenge for the company has come from the covid-19 pandemic, which led to the closure of all clinical trials in Spain and, once they were restarted, they suffered an increase in patient recruitment times. In the specific case of Oncostellae, this led to significant delays in the execution period of one of the clinical trials being carried out at that time.

Galician biotechnology ecosystem

As one of the key companies in the Galician biotechnology sector, Oncostellae emphasizes that "in recent years the Xunta de Galicia, through the Axencia Galega de Innovación, has made an important commitment to the biotechnology sector, which has meant that the drug discovery sector has been enormously boosted within the Galician biotechnology ecosystem," he remarks. "A high quality of services and collaborations in chemical synthesis, in vitro and in vivo pharmacology, clinical trials, etc. can be found in the Galician ecosystem. Oncostellae's projects are largely nourished by this ecosystem in all its phases. It is worth noting in this regard that the phase 2 clinical trial of OST-122 was coordinated from the Hospital Clínico Universitario de Santiago, which has great professionals, opinion leaders in gastrointestinal tract diseases," he mentions.

In addition, they point out that "the Xunta de Galicia has generated financing instruments that have largely met the needs of the sector. In the case of Oncostellae, it is worth mentioning the Conecta Peme Program, which allowed us to finance the first R&D phases of the company's programs; or the support of XesGalicia as a partner of Oncostellae, which was also joined by other funds of the Galician ecosystem such as Unirisco Galicia or recently the also Galician fund Bio & Tech Smart Capital managed by Noso Capital".

Oncostellae's main strengths "lie in the value of the team and its experience in drug development, as well as in the network of collaborators and investors".  The company's main challenges for the coming years are to advance the current programs to reach a licensing agreement with a third party that has sufficient capacity to bring these programs to market and, with the returns obtained, to initiate new programs that will allow the company to grow and consolidate.